Among viral diseases, hepatitis C and AIDS, of which therapies have recently become a matter of serious concern, remain to be sufficiently clarified partly because the nature of the diseases had been kept unknown for a long time owing to the wide variation of the pathogenic viruses themselves. Therefore, the incidence of the secondary infection by these viruses was very high, and increase of patients could not effectively be suppressed. However the remarkable development in the gene-analytical technique in recent years has clarified the primary structure of the viruses in succession, so that the methods for detection of the viruses have been established at last and have eventually slowed down the spread of the secondary infection. It was found that in any of the above-mentioned viruses, the primary structure of the core protein is kept almost unvaried while the envelope protein is very variable. In addition, the progress in the gene technology has made it possible to mass-produce such proteins. In these circumstances, methods have been developed for detection of anti-viral antibodies formed in the serum of the patient, by using the envelope protein and also the core protein as the antigen, and these methods are now widely used in the routine examination.
However, these methods are problematic partly because they cannot make any definite statement as to the presence of infection for at least a few months, a period from the occurrence of viral infection until the formation of antibody within the virus-infected patient, so that they cannot effectively prevent the secondary infection, and partly because with these methods, diagnosis is difficult owing to false-negative results frequently obtained in patients with autoimmune diseases such as collagen disease. There is another problem that the test for the antibody alone cannot always draw a correct conclusion as to the presence of infection in a child infected by the mother-to-child route because he/she has the antibody inherited from his/her mother.
Additionally, RT-PCR method (reverse transcriptase-polymerase chain reaction method) to amplify its gene is used to detect RT (reverse transcriptase), which is relatively long maintained its primary structure consists in the viral agglutination test agent prepared by immobilizing molecules having affinity for the envelope protein of viruses onto the surface of solid microcarriers.
The viral agglutination test agent of the present invention is available for detecting DNA virus (Parvovirus, Papovavirus, Herpes virus, Hepatitis B virus (HBV), etc.,) and RNA virus [Paramyxovirus, Togavirus, Retrovirus (human immunodeficiency virus (HIV), Human T-lymphotropic virus (HTLV-1), etc.,), Hepatitis C virus (HCV), etc.,], especially available for detecting HIV and HCV.
Molecules having affinity for the viral envelope protein used in this invention are desirably proteins [monoclonal antibodies (anti-gp120 monoclonal antibody, anti-HCV monoclonal antibody, anti-HBV monoclonal antibody, anti-Herpes Simplex Virus I monoclonal antibody, anti-Herpes Simplex Virus II monoclonal antibody, anti-Varicella Zoster Virus II monoclonal antibody, anti-Cytomegalovirus monoclonal antibody, anti-Epstein-Barr Virus monoclonal antibody, anti-Measles Virus monoclonal antibody, and anti-HTLV-1 monoclonal antibody, etc.), polyclonal antibody, CD4, etc.] such as antibodies, or peptides (anti-gp120 polypeptide, etc).
The subject matter of the virus test kit of this invention consists in that the kit contains the above viral agglutination test agent and the positive control reagent. It is desirable that the kit contains the negative control reagent as well.
The positive control reagent is desirably the one prepared by immobilizing a part of or the whole of the viral envelop protein onto the surface of solid microcarriers, while the negative control reagent contains desirably a part of or the whole of the viral envelop protein.